Ann: GENERAL: PEB: PE Releases New Product Cxbladder Monitor

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• Summary: GENERAL: PEB: PE Releases New Product Cxbladder Monitor
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					PEB
24/12/2015 10:20
GENERAL
NOT PRICE SENSITIVE
REL: 1020 HRS Pacific Edge Limited

GENERAL: PEB: PE Releases New Product Cxbladder Monitor

24 December 2015

Pacific Edge Releases New Product Cxbladder Monitor

Cancer diagnostics company, Pacific Edge Limited (NZX: PEB), has today
released Cxbladder Monitor, its third new product in a suite of tests for the
detection and management of bladder cancer. The test is now available in New
Zealand and will be launched in other markets progressively over 2016 and
2017, starting with the USA later in 2016.

Worldwide, bladder cancer is the ninth most prevalent form of cancer and has
a very high recurrence rate. Therefore, bladder cancer patients live in a
world of ongoing monitoring and clinical intervention. Cxbladder Monitor is a
proprietary test for urologists who are monitoring patients with bladder
cancer for recurrence of the disease.

It is designed to be used on patients as part of their ongoing surveillance
regime to quickly and accurately identify those who have a low probability of
having recurrent cancers, providing ongoing reassurance to clinicians and
their patients that the cancer hasn't returned, or supporting the case for
further urological investigation.

Cxbladder Monitor follows in the footsteps of Pacific Edge's first two
molecular diagnostic tests, Cxbladder Detect and Cxbladder Triage. Cxbladder
Triage rules out patients who have a low probability of having cancer and
Cxbladder Detect is used specifically to detect cancer. Both are used in the
early evaluation in patients who present to the urologist with haematuria
(blood in the urine and an early symptom of bladder cancer).

The introduction of Cxbladder Monitor rounds out the Cxbladder family of
products with a one-stop-shop solution from preliminary evaluation of
haematuria, to diagnosis within the urological evaluation as an adjunct to
cystoscopy, right through to post-treatment surveillance for recurrence of
bladder cancer.

Pacific Edge Chief Executive Officer, David Darling, said: "The launch of
Cxbladder Monitor complements our existing Cxbladder products and takes us a
step closer to being able to provide a 'one-stop shop' of accurate
non-invasive tests for urologists.
"Depending on the stage and grade of the initial cancer diagnosis, medical
guidelines advocate follow-up cystoscopies every three months for the first
couple of years post treatment, then six-monthly after that and annually
after five years.

Adding to that, 50-70% of high grade tumours have a recurrence and this
resets the clock for surveillance meaning a longer period of evaluation and
even more cystoscopies.

"Cxbladder Monitor will quickly and easily provide urologists with greater
certainty of their clinical evaluations, the perfect adjunct test to
cystoscopy."

 A number of urologists in the USA and New Zealand have been involved in the
clinical evaluation of Cxbladder Monitor, including NZ-based Dr Peter
Gilling, who in addition to his clinical practice has recently been made
Professor of Surgery at Auckland University.

ENDS

For more information contact:

David Darling
Chief Executive Officer
Pacific Edge Ltd
P: +64 (3) 479 5800

ABOUT Pacific Edge
www.pacificedge.co.nz
www.pacificedgedx.com

Pacific Edge Limited (NZX: PEB) is a New Zealand based cancer diagnostic
company specialising in the discovery and commercialisation of diagnostic and
prognostic technology for the early detection and monitoring of cancer. The
company is developing and commercialising its range of Cxbladder bladder
cancer tests. Its first commercial product, Cxbladder Detect, is now being
actively marketed to physicians and clinicians in New Zealand, Australia, and
the USA through the company's wholly owned subsidiaries and selected
commercial partners.

ABOUT bladder cancer

Globally, bladder cancer has the 9th highest incidence and the 4th highest
incidence for men. It has the highest total medical costs of any cancer per
patient, which in the US approaches $240,000. One of the early symptoms of
bladder cancer is the presence of blood in the urine, haematuria. People with
haematuria often present to their general practitioner before being referred
on to a urologist. Bladder cancer has a very high recurrence rate of
approximately 50%-70% with up to 30% of these recurring as later stage
tumours. However, bladder cancers are highly treatable, especially if
detected in the early stages when there is a much higher probability of
survival. Timely detection and regular surveillance and monitoring of this
cancer is a key element of the clinical process and of the individual's
annual healthcare plan.

ABOUT Cxbladder Detect
www.cxbladder.com

Cxbladder Detect is a proprietary, accurate molecular diagnostic test that
enables the non-invasive detection of bladder and other urinary tract cancers
from a small volume of urine. Cxbladder Detect is commercially available in
New Zealand, Australia and the USA. Cxbladder Detect is available in the USA
and NZ as a Laboratory Developed Test (LDT) from the company's CLIA certified
laboratories, providing physicians and clinicians with a quick, cost
effective and accurate measure of the presence of the cancer, and provides
urologists with an effective adjunct to cystoscopy. The Cxbladder Detect
cancer detection test has been validated by a multi-centre, international
clinical study.

ABOUT Cxbladder Triage
www.cxbladder.com

Cxbladder Triage is a proprietary, accurate and non-invasive molecular test
that combines the power of the genomic biomarkers with extra phenotypic and
clinical risk factors to accurately identify and remove patients with
haematuria who have a low probability of urothelial cancer, from needing to
have a full-urological work-up. This is a tool for use by clinicians and
physicians in the primary evaluation and is intended to reduce of the number
of patients needing an expensive and invasive work-up for urothelial cancer.

ABOUT Cxbladder Monitor
www.cxbladder.com

Cxbladder Monitor is a proprietary, accurate and non-invasive molecular test
that combines the power of the genomic and clinical biomarkers to accurately
identify those patients that have a low probability of having a recurrent
disease. This test is expected to be used by urologists to compliment their
cystoscopies when evaluating patients who are returning to the clinic. As a
consequence, patients with a low probability of urothelial cancer may
therefore not require further invasive procedures. This is a tool for use by
urologists in the post-treatment surveillance of urothelial cancer and is
intended to be used in conjunction with cystoscopy and reduce of the number
of expensive and invasive work-up for urothelial cancer for some patients.
End CA:00275764 For:PEB    Type:GENERAL    Time:2015-12-24 10:20:29